Amarin Corp Plc (AMRN)

[HDGabor]

M-

decision on EU would be made by Q3

He said

we and our advisors intend to continue the dual evaluation of direct versus partner commercialization of VASCEPA in Europe with a goal of finalizing a decision by Q3 2020

together with

our anticipated Pan European recommendation for approval of VASCEPA by the European Medicines Agency near the end of this year.

If the anticipated Pan European recommendation for approval will be later (could be by several method) the 'goal' could be later also.

If I were:
(i) request an extension of time to reply Day 120 letter
(ii) give a reply that trigger the phase 3 of the review (additional 30 days)

We will see.

Best,
G

ps.: previously they guides "approval", now "recommendation for approval" before EOY. The difference is 2 months, the Committee has (IIRC) 67 days to accept / confirm CHMP Opinion / recommendation